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NDA Vs. OTC Drug Monograph

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alchemist04's version from 2018-03-19 21:59

differences BTW NDA and OTC Processes

NDA ProcessOTC Monograph Process
Pre-market approvalNo pre-market approval
Confidential filingPublic process
Drug product- specific (both Active and non active ingredients)Active ingredient-specific
Potential for marketing exclusivity (patent)No marketing exclusivity
Mandated FDA review timelinesNo mandated timelines
May require studies on label comprehension and actual useDoes not require studies on label comprehension and actual use studies
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